Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Dr. Heidi Overton And The FDA: An Outsourcing Perspective

There’s something sadly predictable about negative media reaction to a woman whose professional accomplishments ought to command attention before anything else, writes Chief Editor Louis Garguilo. "But what interests others heading into the Heidi Overton nomination process for FDA Commissioner is whether she can guide the FDA to help us get medicines developed, manufactured, and approved. So what kind of FDA does the outsourcing supply chain need?"

GUEST COLUMNISTS

You Can't CAPA What You Can't Classify
An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.
AI Fills The Decision-Making Gaps In Process Analytical Technology
When combined, artificial intelligence and PAT help move beyond reactive quality testing to proactive and anticipatory process management.
Is mRNA Manufacturing Overbuilt?
mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.
Using Digital Platforms To Find Your CDMO
In recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.
FDA Issues New Guidance On Therapeutic Equivalence
The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?
July 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
ADC CDMO Selection For Small Biotech
Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.

PHARMA OUTSOURCING WHITE PAPERS

RNA Nanoparticle: Formulation, Process, And Characterization
Explore the current state-of-the-art in RNA nanoparticle formulation, examining the technologies and strategies used to optimize RNA delivery for preclinical and clinical development.

Life Cycle Assessment Of Extended Use Strategies For Single-Use Assemblies
Examine how extending the use of single‑use assemblies can significantly reduce emissions, resource consumption, and waste in bioprocessing, offering a data‑backed path toward sustainability.
Optimizing Poloxamer 188
Poloxamer 188 stabilizes proteins in liquid formulations and protects cells from shear stress. Molecular weight and hydrophobicity variations influence its effectiveness in different biopharmaceutical applications.
Mastering Modern Challenges In Drug Development Through Expert Technology Transfer
Drawing on experience from hundreds of successful transfers, our experts recognize that informed decision-making at critical junctures can determine whether a program maintains momentum or loses it.
Building Excellence In Pharma Manufacturing Through Rigor
A rigorous, proactive approach is essential for excellence in pharmaceutical manufacturing. Learn how embedding rigor in systems, workflows, and workforce capabilities improves compliance and efficiency.
Flexibility In Drug Development: From Tactical Response To Strategic Imperative
Build flexibility into your drug development strategy to navigate change effectively, maintain momentum, and drive successful outcomes across every stage of the lifecycle.